Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx ...
FDA Recall #D-0569-2025 — Class I — June 27, 2025
Product Description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Reason for Recall
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Recalling Firm
Sandoz Inc — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
208,300 vials
Distribution
Nationwide in the USA
Code Information
Lot # PG4360, PG4362, Exp. 11/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated